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Completed

NCT Number: NCT04805073

Treatment of Pruritus With Intramuscular Promethazine

Neuraxial narcotics are commonly used in obstetric patients for cesarean delivery to help with pain control over the first 24 hours after the surgery. The aim is to evaluate effectiveness of promethazine (IMP) treatment of intrathecal morphine induced pruritus (ITIMIP). A treatment for ITMIP, other than naloxone, will allow for increased use of intrathecal narcotics and decrease the use of systemic opioids in the initial post-operative period.

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Key information

Conditions

Pruritus Pathological Conditions, Signs and Symptoms Pregnancy Related Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth
  • Willing to consent to study.

Exclusion criteria

  • Male patients
  • Incarceration
  • Inability to communicate with the investigators
  • Allergies to any medications used in the study
  • Possessing any contraindication to spinal anesthesia (lack of consent, elevated intracranial pressure, preexisting neurological disease, thrombocytopenia/coagulopathy, hypovolemia, infection at the site of the procedure)
  • Patients with an already prolonged QTc (>500 ms)
  • Any reason an investigator believes study participation would not be in the best interest of the potential subject.

Treatment and study plan

Promethazine

Drug

1cc 25mg/ml Promethazine (study medication)

Other names: Phenergan

Placebo

Drug

1cc 0.9% Sodium Chloride (placebo)

Other names: salt water

Primary outcomes

  1. Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?

    Time frame: Within first 24 hours after cesarean section

    Pruritus (itching) will be quantified by the ItchyQuant Scale. The ItchyQuant scale is a 0 -10 scale with 0 denoting no itch and 10, the worst itch possible. Participants were asked at 3 different time points (1 hour, 4 hours and 24 hours) after surgery to rate their itching. In the results here we reported any itching (a score greater than zero on the ItchyQuant scale) at 24 hours after surgery in each group.

Secondary outcomes

  1. Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?

    Time frame: Within first 24 hours post cesarean section

    Level of consciousness will be quantified by the RASS Scale. The RASS scale is scored with +4 to -5 scale with +4=combative, 0=alert and calm and -5=unrousable. Participants were asked at 3 different time points (1 hour, 4 hours and 24 hours) after surgery to rate their level of consciousness. In the results here we reported any score not noted to be 0 (alert and calm) at 24 hours after surgery in each group.

  2. Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?

    Time frame: Within first 24 hours post cesarean section

    We asked patients to rate their sensation of nausea and/or vomiting as none, mild, moderate or severe at 4 time points after cesarean (1 hour, 4 hours and 24 hours after cesarean). Here, we rate any report of nausea and/or vomiting as opposed to no nausea and/or vomiting at 24 hours after cesarean among the patients who had Promethazine and normal saline.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2021
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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